Auxein Medical Private Limited

Certificat C721730

Rév. 2Délivré

Valide jusqu'au: 16 oct. 2029

Le certificat C721730 est un certificat Système de management de la qualité valide délivré à Auxein Medical Private Limited et enregistré dans EUDAMED. Valable jusqu'au 16 octobre 2029. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: C721730
Type de certificat: Système de management de la qualité
Statut du certificat: Délivré
Législation applicable: MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]
Version: 1
Identifiant du certificat: 2460C7217302

Validité

Délivré le: 17 oct. 2024
Valide à partir du: 17 oct. 2024
Valide jusqu'au: 16 oct. 2029

Fabricant

Fabricant: Auxein Medical Private Limited
SRN du fabricant: IN-MF-000018837
Pays du fabricant: Inde

Organisme notifié

Organisme notifié
SRN de l'organisme notifié: 2460
Pays de l'organisme notifié: Norvège

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

: Oui
: Non
: Non
: Non
: Oui
: Non
: Non
: Oui
: Oui
: Non
: Non
: Non

Historique

Aucun changement de statut ni certificat précédent enregistré.

Périmètre de couverture

Classe IIb19

19 périmètres

Femur Nailing System (Sterile/Non-Sterile) The femur nail system is intended to Stabilize Femoral shaft fractures, Trochanteric Fractures, Ipsilateral Neck and Femoral Head, Impending Pathologic Fractures, Nonunions and Malunions of femur bone.
Classe IIb
Tibia Plate System (Sterile/Non-Sterile) Device is intended to treat Non-union, Malunions and fracture of tibia bone.
Classe IIb
Foot Plate System (Sterile/Non-Sterile) The Foot Plate System is intended to treat Non- union, Malunions and fracture of foot bone
Classe IIb
Radius Plate System (Sterile/Non-Sterile) The Radius Plate System is intended to treat Non- union, Malunions and fracture of Radius bone.
Classe IIb
Humerus Plate System (Sterile/Non-Sterile) The Humerus Plate System is intended to treat Non- union, Malunions and fracture of Humerus bone.
Classe IIb
Components of shoulder arthroscopy system (sterile) Components of Shoulder Arthroscopy System is indicated for use in the fixation of muscles, ligaments and tendon in patients requiring muscle, ligament or tendon repair
Classe IIb
Components of Knee arthroscopy system (sterile) o Naked Button
Classe IIb
AJAX Advance Nail, Short and Long (Left/Right), Titanium with AJAX 4.9mm Locking Bolt, Self- Tapping, Titanium o AJAX Blade, Titanium o AJAX Nail End Cap (For Ajax Blade), Titanium o AJAX Nail End Cap (For Cephalic Screw), Titanium o Inner Screw for Ajax Cephalic Screw, Titanium o AJAX Cephalic Screw, Titanium o End Cap for Ajax Cephalic Screw, Titanium
Classe IIb
Expert Femur Nail, Left/Right, Stainless Steel/Titanium with o End Caps for Expert Femur Nail, Stainless Steel/Titanium o Ø4.8mm Locking Bolt, Self- Tapping, For Expert Femur Nail, Stainless Steel/Titanium o Ø6.4mm Cannulated Anti- Rotation Screw, Self-Tapping, For Expert Femur Nail, Stainless Steel/Titanium
Classe IIb
Retrograde Femur Nail, Stainless Steel/Titanium with5.0mm Locking Screw for Retrograde Femur Nail, Stainless Steel/Titanium o End Cap for Retrograde Femur Nail, Stainless Steel/Titanium
Classe IIb
ATHOS Nail, Stainless Steel/Titanium following Variants o 125° Athos Nail Type-II, Short, Stainless Steel/Titanium o 125° Athos Nail Type-II, Long, Left/Right, Stainless Steel/Titanium o 130° Athos Nail Type-II, Short, Stainless Steel/Titanium o 130° Athos Nail Type-II, Long, Left/Right, Stainless Steel/Titanium o 125° Anti-Rotation Athos Nail, Short, Stainless Steel/Titanium o 125° Anti-Rotation Athos Nail, Long, Left/Right, Stainless Steel/Titanium o 130° Anti-Rotation Athos Nail, Short
Classe IIb
JIN-Type Femur Nail, Stainless Steel/Titanium with o End Cap for JIN Type - Femur Nail, Stainless Steel/Titanium o Ø4.5mm Locking Bolt, Self- Tapping, For JIN Type – Femur Nail, Stainless Steel/TitaniumKONZEPT Femur Nail also known as Universal Intramedullary Cannulated Femur Nail, Left/Right, Stainless Steel/Titanium with End Cap for Universal Intramedullary Cannulated Femur Nail M10 X 1, Stainless Steel/Titanium
Classe IIb
Tibia Plates: (Stainless steel and Titanium), Left/Right o 3.5mm AV-Wiselock Proximal Tibia Plate, Small Bend o 3.5mm AV-Wiselock Proximal Tibia Plate, Large Bend o 3.5mm AV-Wiselock MedialProximal Tibia Plate o 4.5/5.0mm AV-Wiselock Proximal Lateral Tibia Plate o 3.5mm Wise-Lock Medial Distal Tibia Plate o 3.5mm Wise-Lock Proximal Tibia Plate o 3.5mm Wise-Lock Medial Proximal Tibia Plate o 3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate 3.5mm Wise-Lock Anterolateral Distal Tibia Plate3.5m
Classe IIb
Bone Screws: (Stainless steel and Titanium) o 2.7mm Wise-Lock Screw, Self- Tapping (Hex Head) o 3.5mm AV-Wiselock Screw, Self- Tapping o 3.5mm Cortical Screw, Self- Tapping (Star Head) o 3.5mm Wise-Lock Screw, Self- Tapping (Hex Head) o 3.5mm Wise-Lock Screw, Self- Drilling, (Hex Head) o 3.5mm Wise-Lock Cancellous Screw, Full Thread, Self- Tapping, (Hex Head)3.5mm Wise-Lock Cancellous Screw, Short Thread, Self- Tapping, (Hex Head) o 3.5mm Cortical Screw, Self- Tapping, (Hex Head)3.5mm
Classe IIb
Foot Plate System: (Stainless steel and Titanium), Left/Right o Ø2.7mm-6.0mm Metatarsal Shortening Implant o 2.4mm AV-Wiselock Endostea Plate, Standard, Left/Right, Titanium o 2.4mm AV-Wiselock Endosteal Plate, Curved, Left/Right, Titanium o 2.7mm AV-Wiselock MTP Fusion M Plate, 0°/5°/10° Dorsiflexion, Left/Right, Stainless Steel/Titanium o 2.7mm AV-Wiselock MTP Revision M Plate, 5°/10° Dorsiflexion, Left/Right, Stainless Steel/Titanium o 2.7mm AV-Wiselock TMT-I Medial Fusion M Platel
Classe IIb
Radius Plate System: (Stainless steel and Titanium), Left/Right o 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Left/Right, Titanium/Stainless Steel Shaft Holes: 2 to 8 Width (mm): 19.5, 22, 25.5 Head Holes: 6, 7 Available in: Narrow, Standard, Wide o 2.4mm AV-Wiselock Distal Radius Volar Plate, Extra-articular, Left/Right, Titanium/Stainless Steel Head Holes: 4, 5 Shaft Holes: 3, 5 o 2.4mm AV-Wiselock Dorsal Distal Radius Plate, Radial Column, Titanium/Stainless Steel Shaft Holes:
Classe IIb
Humerus Plate System: (Stainless steel and Titanium), Left/Right o Pheelos-3.5mm AV-Wiselock Proximal Humerus Plate with Suture Cuts, Short and Long, Titanium/Stainless Steel o Pheelos - 3.5mm Wise-Lock Proximal Humerus Plate, Short and Long, Titanium/Stainless Steel o 3.5mm Wise-Lock Periarticular Proximal Humerus Plate, Titanium/Stainless Steel o 3.5mm Wise-Lock Proximal Humerus Plate, Titanium/Stainless Steel o 3.5mm Small "T" Plate, Right Angled, Titanium/Stainless Steel o 3.5mm Small "T"
Classe IIb
Titanium Screw-in Anchor with Needle o Titanium Screw-in Anchor without Needle o PEEK OPTIMA Screw In Anchor With Needle o PEEK CF Screw In Anchor With Needle o PEEK OPTIMA Screw In Anchor Without Needle o PEEK CF Screw In Anchor Without Needle o PEEK OPTIMA AuxPik Suture- Based Anchor o PEEK CF Knotless Anchor with Driver o PEEK CF Knotless Anchor without Driver o Rotador PEEK CF Screw In Knotless Anchor o PEEK CF Push In Anchor Without Needle o PEEK CF Push In Anchor with Needle o Rotador
Classe IIb
Naked Button o Adjustable Loop Button o Mini Loop Button o Large Loop Button o Button Extender o AUXILOCK® GFS No-Button Adjustable Loop o AUXILOCK® GFS Concave Button o PEEK CF Interference Screw o PEEK OPTIMA Interference Screw o Titanium Interference Screw o Ligament Staple o MENISCO Inside-Out Meniscal Repair Needle o MENI-FIX All-Inside Meniscal Repair System o AUXILOCK BioBraid
Classe IIb

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